Biosimilar Legal Landscape: Lessons From 2017

 
• By Brenda Sandburg
  
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In several firsts last year, US Supreme Court ruled on BPCIA, Amgen won a damages award in infringement litigation, and Amgen and Mylan inked deals clearing way for future launch of Humira and Herceptin biosimilars. Chart includes status of 15 cases and questions teed up for courts to tackle in 2018.

Pink Sheet Perspectives 2017 - 2018

Last year was filled with milestones in the biosimilars space. The US FDA approved five new products, bringing the total number of biosimilars licensed in the States to nine. The Supreme Court issued a landmark decision giving biosimilar sponsors greater flexibility in litigating patent infringement suits with innovators. Amgen Inc. won the first jury verdict in a biosimilar dispute and was awarded damages for Hospira Inc.'s pre-approval manufacture of its proposed biosimilar to Epogen (epoetin alfa). And Amgen reached a settlement with AbbVie Inc. setting a timeframe for the launch of its biosimilar to Humira (adalimumab).

The litigation has been crucial in determining how patent disputes will be resolved and how quickly biosimilars can get on...

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